CN102552706B - Medicine for treating vascular dementia and preparation method thereof - Google Patents
Medicine for treating vascular dementia and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a medicine for treating vascular dementia, which is prepared by the following crude medicines according to parts by weight: 10-30 parts of gastrodia elata, 10-60 parts of sealwort, 10-60 parts of fructus ligustri lucidi, 3-15 parts of lumbricus, 1-15 parts of leech and 6-40 parts of rhizoma acori graminei. The medicine takes six crude medicines as active ingredients; and the medicine is prepared by acceptable accessories or auxiliary components on pharmacy; and the medicine can be table, capsule, pill, granules, oral liquid or mixture. The invention further discloses a preparation method of the medicine, specifically the specific preparation method for the pill. The medicine prepared by the method is capable of improving the abnormal behaviour of sufferers obviously and improving life quality; the medicine has no obvious toxic or side effects and adverse effect; and the clinical dosage is safe and reliable. The preparation method provided by the invention is advanced; the quality is steady and controllable; the content meets the standard; and the drug test index is qualified so as to ensure the safe and effective clinical medicine.
Description
Technical field
The present invention relates to a kind of Chinese medicine, refer to particularly a kind of medicine and preparation method for the treatment of vascular dementia.
Background technology
Vascular dementia is to cause brain function decline a kind of syndrome to a certain extent because of cerebrovascular disease factors such as multiple infarct.Along with the aging of population, one of the dull-witted commonly encountered diseases that has become harm humans health and frequently-occurring disease.And vascular dementia is the main Types of senile dementia, its sickness rate also constantly rises.The national dull-witted epidemiology statistics data of China also shows, along with the aging of population, the change of dietary structure, the morbidity of vascular dementia is increase trend.Therefore, the method for exploring effectively treatment and prevention vascular dementia becomes an important topic in geriatrics field, also becomes the heat subject of Chinese medicine scholar research.
If treat at present the drug main cholinergic drug of vascular dementia on domestic and international market, common is mainly cholinesterase inhibitor, but the therapeutic effect of Western medicine is not very desirable, and all has side effect, is not suitable for long-term taking.In recent years, Chinese medicine has good curative effect preventing, control vascular dementia, and clinical report can confirm to improve to a certain extent dementia symptom or delay dull-witted progress.But the treatment advantage of Chinese medicine is not to give prominence to especially, the generally acknowledged animal model of vascular dementia yet lacks at present in addition, and safety can not be estimated.
Summary of the invention
In order to address the above problem, primary and foremost purpose of the present invention is to provide the medicine of a kind of good effect, safe treatment vascular dementia.
Another object of the present invention is to provide the preparation method of the medicine of above-mentioned treatment vascular dementia.
Through the exploration of clinical practice for many years, show that the internal organs of vascular dementia win partially, negative and positive deficiency and excess, it is after apoplexy, and its pathogenesis be take caused by liver and kidney deficiency as basis, but belongs to deficiency of kidney essence more; Expectorant becomes silted up and hinders network, is the card of deficiency in origin and excess in superficiality, establishes principle for the treatment of-replenishing essence blood stasis dispelling of " strengthening vital QI to eliminate pathogenic factors ", and Fructus Alpiniae Oxyphyllae is had one's ideas straightened out, and obtains a large amount of clinical practices confirmations.With this, coach, in conjunction with clinical experience, determine formulation principle, select the meticulous prescription of effective Chinese medicine to be used for the treatment of vascular dementia.
The medicine that the present invention treats vascular dementia is the medicament of being made by the crude drug of following portions by weight: 10～30 parts, Rhizoma Gastrodiae, 10～60 parts of Rhizoma Polygonatis, 10～60 parts of Fructus Ligustri Lucidi, 3～15 parts of Pheretimas, 1～15 part of Hirudo, 6～40 parts of Rhizoma Acori Graminei.
Preferred weight part ratio range of medicine of the present invention is: 20～30 parts, Rhizoma Gastrodiae, 30～60 parts of Rhizoma Polygonatis, 40～60 parts of Fructus Ligustri Lucidi, 10～15 parts of Pheretimas, 5～10 parts of Hirudos, 20～35 parts of Rhizoma Acori Graminei.
Optimum weight part proportioning of medicine of the present invention is: 30 parts, Rhizoma Gastrodiae, 50 parts of Rhizoma Polygonatis, 50 parts of Fructus Ligustri Lucidi, 15 parts of Pheretimas, 5 parts of Hirudos, 30 parts of Rhizoma Acori Graminei.
Rhizoma Gastrodiae: this product is the dry tuber of orchid Rhizoma Gastrodiae Gastrodia elata Blume.After the Beginning of Winter, to Clear and Bright next year, excavated, clean immediately, steam thoroughly, open wide cold drying.Rhizoma Gastrodiae nature and flavor are sweet, flat, return Liver Channel.There is the effect of suppressing the hyperactive liver to relieve the wind syndrome relieving convulsion.Be used for having a headache dizzy, numb limbs and tense tendons, infantile convulsion, epilepsy clonus, tetanus.This product is containing neutral substance and Alkaloid, phlegmatic temperament in Vanillyl alcohol, Vanillyl aldehyde, retinoid material, glycoside, crystallinity.Its main pharmacological is: (1) effect to central nervous system: 1. anticonvulsant action.2. sedative-hypnotic effect.3. analgesic activity.4. nootropic effect: Rhizoma Gastrodiae can improve cognitive function and the acquired disturbance of learning and memory of little mouse, improves the short term memory of mouse aging; Rhizoma Gastrodiae alcohol extract is to the mouse memory ability that improves significantly of the mouse memory damage tool due to scopolamine, sodium nitrite, ethanol; Rhizoma Gastrodiae can make rat brain glial cells hyperplasia significantly, and quantity increases, and glial cell group ground area increases, to enlivening neuron, strengthen study, memory function plays supporting function.(2) effect to cardiovascular system: 1. synthetic gastrodin can make Cultured Rat Cardiac Beating Rate accelerate, and contractility strengthens, rhythm and pace of moving things rule.2. the impact on blood vessel and blood pressure, the resistance of reduction body blood vessel, cerebrovascular and coronary vasodilator, increases cerebral blood flow; There is gentle hypotensive effect.3. on microcirculatory impact.The quiet notes of Gastrodia Injection, can obviously expand anesthetized rat mesentery arteriole caliber, and blood flow is accelerated.(3) anti-infectious function.(4) enhancing human body immunity ability.(5) resisting oxygen lack.(6) delaying senility function: injection can improve superoxide dismutase in blood (SOD), glutathion peroxidase (GSHPx) vigor and have endurance effect Gastrodia Injection to mouse peritoneal, can shorten the development time of drosophila larvae, extend the life-span of adult; Gastrodia elata polysaccharide has obvious inhibitory action to liver lipid peroxidation enzyme, can promote the synthetic of body DNA and protein.
Rhizoma Polygonati: this product is the dry rhizome of liliaceous plant Yunnan Rhizoma Polygonati Polygonatum kingianum Coll.etHemsl., Rhizoma Polygonati Polygonatum sibiricum Red. or Polygonatum cyrtonema Hua Polygonatum cyrtonema Hua.Different by shape, practise and claim " large Rhizoma Polygonati ", " polygonatum sibiricum Redoute " " RHIZOMA POLYGONATI ZINGIBERIFORME ".Spring, Qiu Erji excavate, and remove fibrous root, clean, and put slightly boiling hot in boiling water or steam the heart extremely thoroughly, dry.Rhizoma Polygonati nature and flavor are sweet, flat.Return spleen, lung, kidney channel.There is boosting qi and nourishing yin, spleen invigorating, lung moistening, kidney tonifying effect.For weakness of the spleen and stomach, fatigue and asthenia, xerostomia lack of appetite, deficiency of the lung cough caused by dryness, asthenia of essence and blood, interior-heat is quenched one's thirst.The mucous matter of this product, starch and sugar.P. cyrtonema is containing azetidinecarboxylic acid, aspartic acid, homoserine, digitalis glucoside and multiple anthraquinone analog compound.Rhizoma Polygonati has the effects such as the immunologic function of enhancing, defying age, anoxia enduring, resisting fatigue, enhancing metabolism, blood sugar lowering, heart tonifying.Various bacteria and dermatophytes are had to inhibitory action.
Fructus Ligustri Lucidi: this product is the dry mature fruit of Oleaceae plants Fructus Ligustri Lucidi Ligustrum lucidum Ait..Gather during fruit maturation winter, removes branch and leaf, after slightly steaming or putting and slightly scald in boiling water, dry; Or convection drying.Fructus Ligustri Lucidi nature and flavor sweet, bitter, cold.Return liver, kidney channel.There is nourishing the liver and kidney, the effect of improving eyesight black hair.For vertigo and tinnitus, soreness of the waist and knees, early whitening of beard and hair, poor vision.This product is containing oleanolic acid, mannitol, glucose, Palmic acid, stearic acid, oleic acid, glyceric acid etc.Have enhancing immunologic function, rising peripheral leukocytes, strengthens reticuloendothelial system phagocytic activity, strengthens the effect of cellular immunization and humoral immunization; The leukopenia of chemotherapy or caused by radiation is had to rising effect; There are heart tonifying, diuresis and hepatoprotective effect; And there are cough-relieving, cathartic, an effect such as antibiotic, anticancer.Fructus Ligustri Lucidi can reduce Experimental Hyperlipoidemia Rabbits serum cholesterol and triglyceride levels, the consumption that is formed with to experimental aorta Lipid Plaque.Fructus Ligustri Lucidi can also significantly suppress Mus brain lipid peroxide formation at advanced age, improves SOD active, reduces MDA content, suppresses the effect of lipid peroxidation of erythrocyte membrane.
The dry body of Pheretima: the animal Pheretima aspergillum Pheretima aspergillum of this product Wei Ju earthworm section (E.Perrier), popular Pheretimatschiliensis Pheretima vulgaris Chen, William Pheretimatschiliensis Pheretima guillelmi (Michaelsen) or the blind Pheretimatschiliensis Pheretima of comb pectinifera Michaelsen.Pheretima nature and flavor are salty, cold, return liver, spleen, urinary bladder channel.Have heat clearing away arresting convulsion, dredging collateral, relievings asthma, diuresis, and for unconsciousness due to high fever, infantile convulsion is twitched, arthralgia, numb limbs and tense tendons, hemiplegia, dyspnea and cough due to lung-heat, oliguria edema, hypertension.This product, containing lumbrifebrine, lumbricin, terrestro-lumbrolysin, contains again nitrogen substance and xanthine, adenine, guanine, choline etc.LUMBRICUS tincture, dry powder suspension, hot dipping liquid, decoct etc., all have slow and lasting hypotensive effect.LUMBRICUS hypoxanthine has significant bronchorelaxing activity ，Bing Neng antagonism histamine and pilocarpine to bronchial contraction; But a kind of moist faint yellow acicular crystal of drawing is proposed from LUMBRICUS, in vitro and have excitation in body uterus.Water decoction and lumbrifebrine all have good refrigeration function.Hot dipping liquid, alcohol extraction solution have calmness, anticonvulsant action.
Hirudo: this product is the dry all of Hirudinidae animal whitmania Whitmania pigra Whitman, Hirudo Hirudo nipponica Whitman or Folium Salicis Babylonicae Hirudo Whitmania acranulata Whitman.Summer, Qiu Erji catch, and with boiling water, scald extremely, dry or cold drying.Hirudo nature and flavor are salty, bitter, flat; Slightly poisonous.Return Liver Channel.There is removing blood stasis, removing blood stasis, the effect of stimulating the menstrual flow, Yong Yu mass in the abdomen mass in the abdomen, blood stasis amenorrhea, injury from falling down.Hirudin in fresh Hirudo salivary gland, overheated and dilute hydrochloric acid destructible.Also contain heparin, antithromboxin, protein etc.The main effective ingredient hirudin of Hirudo is the strongest thrombin special efficacy inhibitor in the world so far, can stop the effect of thrombin to Fibrinogen, hinders blood coagulation.The rat suppository that bacterial endotoxin is caused is formed with preventive effect, and can reduce the mortality rate of rat.Contained heparin also has blood coagulation resisting function.Hirudo has Absorption to Laboratory brain blood swelling, can alleviate surrouding brain tissue inflammatory reaction and edema, alleviates intracranial hypertension, improves local blood circulation, is conducive to the recovery of function of nervous system.
Rhizoma Acori Graminei: this product is the dry rhizome of acorus gramineus araceae plant Acorus tatarinowii Schott.Autumn, two seasons of winter excavate, and remove fibrous root and silt, dry.Rhizoma Acori Graminei nature and flavor are pungent, bitter, temperature, GUIXIN, stomach warp.There is removing dampness appetizing, the eliminating phlegm of having one's ideas straightened out, refreshment nootropic effect, not hungry for gastral cavity painful abdominal mass, mouthful dysentery of keeping silent, coma epilepsy, forgetful deafness.This product, containing volatile oil 0.11%～0.42%, is wherein mainly beta-Asarone, α-asaricin, asaricin etc.; Still contain aminoacid, organic acid and saccharide.Rhizoma Acori Graminei water decoction, volatile oil or asaricin, beta-Asarone all have sedation; Water decoction has anticonvulsant action; Guinea-pig isolated trachea and ileum are had to very strong spasmolysis.Decoct can be secreted by facilitating digestion liquid, prevents the abnormal fermentation of gastrointestinal.High concentration leachate has inhibitory action to Common Pathogenic dermatophytes.Rhizoma Acori Graminei can promote the acquisition of normal mouse learning and memory.
Rhizoma Polygonati sweet in the mouth is flat, has the effect of good nourishing YIN for benefiting the kidney, the power of useful air culture soil again, and the first giving young employees remedial-courses in general knowledge and vocational skills day after tomorrow is to be monarch drug.Rhizoma Gastrodiae sweet in the mouth and property are flat, can relieving spasm by subduing liver-wind, suppressing the hyperactive liver and subsiding YANG, control the dementia after apoplexy, and have much the meaning of " blocking ", be minister.Fructus Ligustri Lucidi bitter in the mouth is cool in nature, function nourishing kidney lung moistening, invigorating the spleen and replenishing QI, the power of reinforcement monarch drug tonify deficiency.Hirudo salty in the mouth is bitter, property is flat, the special removing blood stasis resolving blood stasis and dredging collateral of merit.Rhizoma Acori Graminei acrid in the mouth is bitter, warm in nature, and removing dampness to restore normal function of the stomach, eliminates phlegm for resuscitation, the mind calming and mentality promoting.Three medicines are principal drug assistance altogether, controls altogether expectorant, the stasis of blood, void, for being adjuvant drug.Pheretima salty in the mouth is cold in nature, have heat clearing away arresting convulsion, dredging collateral relieving asthma, can clots absorbing dredging collateral, the sedate of invigorating blood circulation, with salty flavor entering the kidney for making.Six medicines share, and play altogether replenishing essence blood stasis dispelling, the merit that Fructus Alpiniae Oxyphyllae is had one's ideas straightened out.
Medicine of the present invention can be used in many ways, as directly decocted with water into decoction, takes; Or be active component by above-mentioned 6 taste crude drug, add the medicament that pharmaceutically acceptable adjuvant or complementary composition are prepared from.Described medicament is tablet, capsule, pill, granule, oral liquid or mixture etc.
According to the physicochemical property of above-mentioned 6 taste Chinese medicines and pharmacological action, extract drugs technique of the present invention and preparation process are studied, obtain comparatively reasonably preparation method of medicine of the present invention, comprise the steps:
A, standby according to described weight proportion weighting raw materials;
B, Pheretima, Hirudo, Rhizoma Acori Graminei are dried, pulverize, sieve, mix and make fine drug powder (I);
It is 1.30～1.40 that C, Rhizoma Gastrodiae, Rhizoma Polygonati, Fructus Ligustri Lucidi decoct, filter, are concentrated into relative density, makes clear paste (II);
D, get fine drug powder (I), clear paste (II) mixes, and adds pharmaceutically acceptable adjuvant or complementary composition to be prepared into pharmaceutically conventional medicament.
When experimental studies have found that this prescription is made the dosage forms such as capsule, mixture, oral liquid, there will be the problems such as dose is large, preparation process is difficult, taste bad will.And Rhizoma Gastrodiae in we, Rhizoma Polygonati, the clear paste that Fructus Ligustri Lucidi extracts, coordinates Pheretima, Hirudo, the medicated powder that Rhizoma Acori Graminei three medicated powder are broken into, can well improve above these problems after making pill, therefore the preferred pill of our dosage form.
The concrete preparation method of the pill of medicine of the present invention is as follows:
A, standby according to described weight proportion weighting raw materials;
B, Pheretima, Hirudo, Rhizoma Acori Graminei are pulverized after drying 68～74 hours in 60 ℃, cross 100 mesh sieves, mix and make fine drug powder (I);
C, Rhizoma Gastrodiae, Rhizoma Polygonati, Fructus Ligustri Lucidi are soaked in water 0.5～1 hour, decoct with water several times, filter merging filtrate, and being concentrated into relative density is 1.30～1.40, makes clear paste (II);
D, get fine drug powder (I), clear paste (II) mixes, and pulverizes, and crosses 60 mesh sieves, with general method for making or mould method for making pill, obtains pill after dry.
In preparing the process of pill, before mixing with fine drug powder (I), the clear paste that C step is made (II) microwave vacuum drying is made dry extract, design temperature is 60 ℃, negative pressure 0.08～0.09mpa, microwave power is 1.50～3.50kw, each 3～5min, and microwave vacuum drying amounts to 15～25min 4～6 times.
The usage of medicine of the present invention and consumption: the dosage of medicine of the present invention depends on concrete dosage form, and the factor such as age of patient, body weight, health status.As guidance: pill, each oral 6g that is grown up, every day 3 times, 12 weeks is a course for the treatment of, treats 1～3 course for the treatment of.
After vascular dementia is mainly in apoplexy, its pathogenesis be take caused by liver and kidney deficiency as basis, but belongs to deficiency of kidney essence more; Expectorant becomes silted up and hinders network, is the card of deficiency in origin and excess in superficiality.It Herba Stellariae Saxatilis ball is reused Rhizoma Polygonati for monarch, has the effect of good nourishing YIN for benefiting the kidney; Rhizoma Acori Graminei resuscitation inducing and mind tranquilizing, removing dampness to restore normal function of the stomach, the kind wet foul and resuscitation inducing and mind tranquilizing that reduces phlegm, the mechanism of qi of logical heart stomach; The special removing blood stasis resolving blood stasis and dredging collateral of Hirudo merit, principal drug assistance is controlled altogether expectorant and is become silted up empty; Assistant with control the key medicine Rhizoma Gastrodiae of slow-witted disease and specially enter Liver and kidney through person's Fructus Ligustri Lucidi.Rhizoma Gastrodiae is controlled the dementia after apoplexy, has much the meaning of " blocking ".Fructus Ligustri Lucidi nourishing kidney lung moistening, invigorating the spleen and replenishing QI, the power of reinforcement monarch drug tonify deficiency.Pheretima blood stasis expelling dredging collateral, the sedate of invigorating blood circulation, be good at sensible meridians.Therefore we are with Pheretima for making, salty flavor entering the kidney, fills in for the moon.Wherein Rhizoma Polygonati, Fructus Ligustri Lucidi, Rhizoma Acori Graminei share false Rhizoma Acori Graminei be amusing appetizing merit and should stop up should key use, Rhizoma Polygonati, Fructus Ligustri Lucidi are mended and oiliness, benefit essence is filled out marrow and without stopping up stagnant fraud, is more had the meaning of linking up warm kidney water, kidney taste heart-fire waterborne under heart kidney, heart-fire, reaches heart kidney essense blood with supporting.Pheretima, Hirudo and Rhizoma Acori Graminei share, and expectorant becomes silted up and controls, and open sharp key effect rather good.Rhizoma Polygonati, Pheretima are with help dredging collateral, active and cause new by QI invigorating.Rhizoma Acori Graminei, Fructus Ligustri Lucidi one be with pungent loose and open its phlegm-damp profit numbness work, one with hardship fall and fixed its against upper expectorant, gas along and expectorant is stopped up from opening, QI and blood Bu Fushang garden.No matter liver-wind fire-transformation, congestion heat-transformation, all causes malaise, expectorant heat is disturbed mutually, Pheretima, Fructus Ligustri Lucidi hold concurrently can clear deficiency and excess heat, mind tranquilizing, spasmolytic arresting convulsion.And Rhizoma Gastrodiae is to control the slow-witted product that must use.Six medicines share, and effect has both and be not numerous, and compatibility is precise and appropriate and bring out the best in each other, selection should, the old side of having of cloth, plays the clearing away phlegm merit that silt, replenishing essence have one's ideas straightened out of dispelling altogether.
Beneficial effect of the present invention: by animal experiment and clinical research confirmation, pharmaceutical composition of the present invention meets Chinese medical theory, meets vascular dementia pathogenesis feature, selects medicine to have modern Chinese medicine pharmacological basis, medical material study of pharmacy shows that our medical material used is pharmacopeia and records, and source is abundant.Through acute toxicity testing, show, Chinese medicine of the present invention is safe in clinical practice.Through clinical observation on the therapeutic effect, show that Chinese medicine of the present invention can obviously improve vascular dementia patient's behavioristics abnormal, improve the quality of living, and without obvious toxic-side effects and untoward reaction, clinical usual amounts is safe and reliable.Preparation method of the present invention is advanced, stable and controllable for quality, content conformance with standard, and medicine inspection qualified, guarantees that clinical drug safety is effective.
The specific embodiment
Embodiment 1
Form: Rhizoma Gastrodiae 300g, Rhizoma Polygonati 500g, Fructus Ligustri Lucidi 500g, Pheretima 150g, Hirudo 50g, Rhizoma Acori Graminei 300g.
Preparation method:
A, standby according to above-mentioned weight proportion weighting raw materials;
B, Pheretima, Hirudo, Rhizoma Acori Graminei are placed in drying room, in 60 ℃, pulverize after drying 72 hours, cross 100 mesh sieves, mix and make fine drug powder (I);
C, Rhizoma Gastrodiae, Rhizoma Polygonati, Fructus Ligustri Lucidi are placed in 100 liters of jacketed pans, are soaked in water 0.5 hour, add water to 20 liters, decoct 1.5h, 12 liters of extracting juice; Add 15 liters, water again, decoct 1h, 6 liters of extracting juice, merge the standing 1h of filtrate of twice decoction, and being concentrated into relative density is 1.38, makes clear paste (II) 0.5kg;
D, the clear paste (II) that C step is made are placed in microwave vacuum dryer, and design temperature is 60 ℃, negative pressure 0.08～0.09mpa, microwave power is set as respectively 2.55kw, 3.40kw, 2.55kw, 1.70kw, each 5min, amounts to 20min, makes dry extract 0.3kg;
E, get fine drug powder (I), dry extract mixes, and pulverizes, and crosses 60 mesh sieves, with general method for making or mould method for making pill, after being dried, must obtain pill 600g.
Embodiment 2
Form: Rhizoma Gastrodiae 10g, Rhizoma Polygonati 10g, Fructus Ligustri Lucidi 10g, Pheretima 3g, Hirudo 1g, Rhizoma Acori Graminei 6g.
Preparation method:
A, standby according to above-mentioned weight proportion weighting raw materials;
B, Pheretima, Hirudo, Rhizoma Acori Graminei are pulverized after drying 68 hours in 60 ℃, cross 100 mesh sieves, mix and make fine drug powder (I);
C, Rhizoma Gastrodiae, Rhizoma Polygonati, Fructus Ligustri Lucidi are soaked in water 0.5 hour, decoct with water 3 times, add for the first time 10 times of water gagings to decoct 2 hours, add for the second time 8 times of water gagings to decoct 1.5 hours, add for the third time 8 times of water gagings to decoct 1 hour.Each decocting liquid staticly settles more than 12 hours, and gradation is filtered.Merge three times filtrate, it is 1.36 that filtrate is concentrated into relative density, makes clear paste (II);
D, get fine drug powder (I), clear paste (II) mixes, and pulverizes, and crosses 60 mesh sieves, with general method for making or mould method for making pill, obtains pill after dry.
The pill of gained is sepia concentrated watered pill, feeble QI raw meat, mildly bitter flavor.
Embodiment 3
Form: Rhizoma Gastrodiae 30g, Rhizoma Polygonati 60g, Pheretima 15g, Fructus Ligustri Lucidi 60g, Hirudo 15g, Rhizoma Acori Graminei 40g.
Preparation method:
A, standby according to above-mentioned weight proportion weighting raw materials;
B, Pheretima, Hirudo, Rhizoma Acori Graminei are pulverized after drying 74 hours in 60 ℃, cross 100 mesh sieves, mix and make fine drug powder (I);
C, Rhizoma Gastrodiae, Rhizoma Polygonati, Fructus Ligustri Lucidi are soaked in water 1 hour, decoct with water at twice, filter merging filtrate, and being concentrated into relative density is 1.40, makes clear paste (II);
D, get fine drug powder (I), clear paste (II) mixes, and pulverizes, and crosses 60 mesh sieves, with general method for making or mould method for making pill, obtains pill after dry.
Animal experiment
Test 1 Chinese medicine of the present invention to the ethological impact of vascular dementia rat models
1. material and grouping: Wistar rat, 10 monthly ages, body weight 250 ± 20g, male and female half and half.Be divided at random blank group, model group, Western medicine group, Chinese medicine high dose group of the present invention, middle dosage group and low dose group.
2. animal model is made rat is weighed after anesthesia with 4% pentobarbital sodium 50mg/kg, lies on the back and is fixed on operating-table, cropping, the conventional sterile working of skin, neck median incision, separated bilateral common carotid arteries (Common Carotid Artery, CCA); With non-invasive bulldog clamp reversibility folder, close bilateral CCA10min immediately, more logical 10min, then folder closes 10min, more logical, then folder closes 10min, more logical, sew up wound then, gentamycin prevention infection is given in part, and in cage, insulation is raised.
3 experimental apparatus rat diving towers
4 processing methods
4.1 medicines: Chinese medicine of the present invention; Western medicine: dihydroergotoxin (Hydergine), produced jointly by Tianjin Hua Jin pharmaceutical factory and Switzerland Shandeshi drugmaker by Dihydroergotoxine, trade name hydergine.
4.2 medication blank groups: normally feed, do not give any medicine.Model group: pure modeling, do not give any medicine.Western medicine group: the continuous gavage 30d of Western medicine after modeling, 1 time/d.Chinese drug-treated group: divide three groups according to the height of drug level after modeling, the continuous gavage 30d of Chinese medicine, 1 time/d.
5 observation contents: learning and memory in rats
Make the passive avoidance response case of one 25cm * 20cm * 75cm size by oneself, at the bottom of case, paving diameter is 1mm copper grid, logical 36V alternating current, tank wall is surrounded by black plastic plate, one jiao of place of safety that fixedly the plastic foam piece of 8cm * 8cm * 5cm size is avoided shocking by electricity and reacting as animal of copper grid.Before training, first animal is placed on the plastic foam piece in reaction chamber and adapts to 3min, then pass to immediately 36V alternating current, animal shocked by electricity after escape reaction for jumping onto on plastic foam piece.Record rat in 5min and find first place of safety required time (incubation period), errors number (animal jumps off place of safety number of times).Train the 7th day test result 6 days.
6 experimental results
6.1 each groups are learned and are detected VD rat behavior
result is as shown in table 1.
Table 1: each group is learned testing result to VD rat behavior
| Group | Incubation period (s) | Errors number (n) |
| Blank group | 9.21±1.96 | 5.6±3.6 |
| Model group | 30.63±4.47 △ | 1.89±6.8 △ |
| Chinese medicine high dose group | 9.93±2.03 * | 7.9±2.8 * |
| Dosage group in Chinese medicine | 14.25±2.33 * | 9.6±3.5 * |
| Chinese medicine low dose group | 16.13±2.9 ** | 11.3±5.9 ** |
| Western medicine group | 10.25±3.11 * | 7.2±3.4 * |
Note: with model group comparison: * P < 0.01, * * P < 0.05; With blank group comparison: △ P < 0.01
6.2 experiment conclusion: vascular dementia model group incubation period and errors number are significantly higher than blank group (P < 0.01), Chinese medicine various dose group of the present invention is compared incubation period with vascular dementia model group and errors number significantly reduces (P < 0.01 or P < 0.05).
6.3 experiments are discussed: diving tower experiment is directly the behavioristics of animal to be measured, it is comparatively objectively index of a kind of evaluation animal learning memory function, this research detects it with diving tower, shorten the incubation period of shocking by electricity of hiding of discovery dementia rats, errors number increases, be that its ability of learning and memory obviously reduces, especially obvious with model group, the preparation that VD rat model is described is successful.After Chinese medicine of the present invention and the treatment of Western medicine Dihydroergotoxine, dementia rats obviously extends incubation period, points out its impaired learning and memory function to be able to remarkable improvement; In exploring the observation of experiment, the exploration number of times of Chinese drug-treated group and Western medicine treated animal, than the obvious increase of model group, points out its memory retention ability to improve.
Test 2 Chinese medicines of the present invention to NO, NOS content detection 1 material and grouping in vascular dementia rat models cerebral tissue: Wistar rat, 10 monthly ages, body weight 250 ± 20g, male and female half and half.Be divided at random blank group, model group, Western medicine group, Chinese medicine high dose group of the present invention, middle dosage group and low dose group.2 animal models are made rat are weighed after anesthesia with 4% pentobarbital sodium 50mg/kg, lie on the back and are fixed on operating-table, cropping, the conventional sterile working of skin, neck median incision, separated bilateral common carotid arteries (Common Carotid Artery, CCA); With non-invasive bulldog clamp reversibility folder, close bilateral CCA10min immediately, more logical 10min, then folder closes 10min, more logical, then folder closes 10min, more logical, sew up wound then, gentamycin prevention infection is given in part, and in cage, insulation is raised.
3 experimental apparatus 721 spectrophotometers, operating scissors, refiner, centrifuge, thermometer
4 Experimental agents 10% chloral hydrate, NO test kit, NOS test kit
5 processing methods
5.1 medicine Chinese medicine of the present invention; Western medicine: dihydroergotoxin (Hydergine), produced jointly by Tianjin Hua Jin pharmaceutical factory and Switzerland Shandeshi drugmaker by Dihydroergotoxine, trade name hydergine.
5.2 medication blank groups: normally feed, do not give any medicine.Model group: pure modeling, do not give any medicine.Western medicine group: the continuous gavage 30d of Western medicine after modeling, 1 time/d.Chinese drug-treated group: divide three groups according to the height of drug level after modeling, the continuous gavage 30d of Chinese medicine, 1 time/d.
5.3 experimental techniques: each group mice is breaked end in batches, cut open fast and get full brain on ice pan, discard olfactory bulb and cerebellum.With ice normal saline flushing blood, then with filter paper, wipe away dryly, add 9 times of cold salines after scales/electronic balance weighing, grind to form 10% homogenate in glass homogenizer, 4 ℃, the centrifugal 5min of 3600r/min, extract supernatant, and-20 ℃ frozen to be checked.In cerebral tissue, the mensuration of NO, NOS content operates in strict accordance with test kit description.
6 experimental results:
NO is a kind of blood vessel, neuroactive substance, there is adjusting cerebral blood flow, promote or suppress mediator to discharge, participate in the multiple effects such as synaptic plasticity and neuronal excitation toxicity and inflammatory injury, and relevant with learning and memory, NO participates in acute cerebral ischemia and VD forms overall process.NO under NOS effect, take L-arginine as substrate synthetic.Research shows, Cerebral Ischemia/Reperfusion and induction Neuron Apoptosis, thus cause that dull-witted learning memory declines.Along with the prolongation of time, can make induced NOS (iNOS) activate, produce the NO in a large number with neurotoxic effect, and NO in forming, hippocampal delayed Neuron Apoptosis and VD has brought into play certain effect.During cerebral ischemia, produce a large amount of NO and oxygen free radical reaction and generate peroxynitrite, and then resolve into the extremely strong oxidant of toxicity, cause the further damage of cerebral tissue.Experimental result shows: VD rat model hippocampus NO level and NOS are active significantly to be increased, and Chinese medicine various dose group of the present invention significantly reduces hippocampus NO level and NOS is active.
Each group on VD rat cerebral cortex organize NO and NOS to affect result as shown in table 2.
Table 2: each group is organized the impact of NO and NOS on VD rat cerebral cortex
| Group | NO(mmol/mg) | NOS(u/mg) |
| Blank group | 853±0.62 | 0.64±0.06 |
| Model group | 14.39±0.8 △ | 1.75±0.16 △ |
| Chinese medicine high dose group | 9.02±0.21 * | 0.75±0.08 * |
| Dosage group in Chinese medicine | 11.93±0.78 * | 0.8±0.06 * |
| Chinese medicine low dose group | 12.94±0.33 ** | 0.9±0.08 ** |
| Western medicine group | 9.39±0.27 * | 0.85±0.09 * |
Note: with model group comparison:
*p < 0.01,
*p < 0.05; With blank group comparison: △ P < 0.01.Conclusion: vascular dementia model group NO content and NO S activity are significantly higher than blank group (P < 0.01).Chinese medicine various dose group of the present invention is compared NO content and active significantly reduce (P < 0.01 or the P < 0.05) of NO S with vascular dementia model group with Western medicine group; High, the middle dosage group of Chinese medicine of the present invention and Western medicine group P > 0.05, not statistically significant.
Acute toxicity test
1. object: observe animal and take tested medicine for a week, to the issuable acute toxic reaction of white mice and recovery extent, evaluate the safety of its clinical application through digestive tract.
2. laboratory animal Kunming mouse, body weight 18～22g, male and female half and half; Feedstuff: graininess; By the laboratory animal department of the Chinese Academy of Sciences of Tongji Medical College, Huazhong Science and Technology Univ., provide.Raise: minute cage enclosed grazing, freely drink water, freely ingest.
3. medicinal distilled water in of the present invention is made into 0.75 grams per milliliter is experimental drug to Experimental agents, and 4 ℃ store for future use.
4. experimental technique is got 20 of healthy mices, male and female half and half, after fasting 24 hours, the experimental drug of giving respectively every day non hor am and afternoon 4 o'clock to prepare is according to 0.8 milliliter/20 grams body weight gavages, observe the situations such as mice activity, diet, breathing, Continuous Observation 7 days, records animal dead number and toxic reaction.
5. experimental result by the observation of a week, finds that animal ordinary circumstance is good, and hair, body weight, secretion and Excreta be without ANOMALOUS VARIATIONS, none animal dead.Calculating white mice is 60 grams/kilogram to the maximum tolerated dose of Chinese medicine gavage of the present invention, and this dosage is equivalent to 166.7 times of clinical every day of human body consumption.After gavage, mice is movable to be reduced, and alleviates gradually 20 none only dead and obviously toxic reactions of mice in 7 days about approximately 1 hour.
6. conclusion
The maximum tolerated dose of the oral Chinese medicine of the present invention of mice is 60g/Kg, and this is 166.7 times of clinical usual amounts every day of being grown up, and result shows the clinical usual amounts use of this medicine oral administration safety.According to statistics Wrightization rule, existing more than 99.99% assurance proves, the LD50 of mice oral administration must be greater than 60mg/g, proves that Chinese medicine of the present invention is oral with common dose, meets the requirement of medicine acute toxicity.
Clinical trial
Clinical trial 1
Diagnosis and treatment standard
1. Western medicine diagnose standard
The diagnostic criteria of 1.1 vascular dementia: adopt the diagnostic criteria (DSM-IV) of Americanism neuropathy association vascular dementia.That is:
There is many-sided cognitive defect, show as following both:
1. memory impairment (can not learn new data and maybe can not recall acquired data)
2. cognitive disorder at least possesses one of following:
A. aphasia;
B. apraxia (although motor function is normal, can not perform an action);
C. agnosia (although sensory function is normal, can not be familiar with or recognition object);
D. carry out the obstacle (planning, organize, arrange order, abstract) of managerial function.
E. above any 1 cognitive defect has caused obvious society or occupational function defect, and before can finding that these functions are obviously not so good as.
3. there is limitation nerveous system sign and symptom (for example, deep reflex is hyperfunction, stretching property plantar reflex, pseudobulbar paralysis, gait disorder, a certain limbs weak); Or there is the laboratory of prompting cerebrovascular disease for example, also can think the cause of disease of this obstacle according to (the many infractions that, relate to cortex and white matter).
4. these defects are not due to due to delirium.
5. above-mentioned infringement can not be explained by other spirit and thymopathy (as depression, schizophrenia etc.).
6. according to ischemic score scale (HIS), carry out evaluation of result, ischemic score (HIS) scoring >=7 minutes.
7. according to relevant medical history, sign and imaging examination, define the diagnosis of cerebrovascular, dull-witted morbidity after cerebrovascular morbidity more than 3 months, and the infringement of cognitive function is sudden or ladder.
, simple and easy Mental status schedule MMSE, makes diagnosis of dementias specialize, quantize to the internationally recognized Intelligence Tests scale of above combination.
1.2 dull-witted calibration
The ability slight: can complete general simple work, social activity is not subject to obvious impact, maintenance is lived on one's own life, Personal hygiene is relative with judgment complete.
Moderate: independent living ability is affected, needs other people treatment in a way.
Severe: every day, life was seriously influenced, needed at any time people to take care of, cannot keep oneself clean, significantly speaking incoherently or silent.
2, TCM syndrome diagnostic criteria is formulated with reference to the guideline of clinical investigations > > of < < new Chinese medicine treatment senile dementia in the < < of National Drug Administration study of tcm new drug guideline (trying) > > (version in 2002).
2.1 Standards of Chinese Medical Syndrome Differentiation
2.1.1 renal deficiency type
Primary symptom: hypophrenia.
Inferior disease: witless expression, soreness of the waist and knees, dizziness and tinnitus, light red tongue, thin fur, deep-thready pulse.
2.1.2 phlegm stagnation syndrome type
Primary symptom: hypophrenia.
Inferior disease: look stiff, nose heave limb is tired, and indigestion and loss of appetite gastral cavity is swollen, pale tongue, greasy fur, rolling pulse.
Possess one of primary symptom and inferior disease above in conjunction with picture of the tongue, pulse condition, can make a definite diagnosis.
2.2 tcm symptom classification scoring criterias
Score-sheet is as shown in table 3, in table with-,+, ++, +++ indicate without, light, in, heavy.
Table 3 tcm symptom classification scoring table
Illustrate: picture of the tongue, pulse condition specifically describe, and do not score.
2.3 traditional Chinese medical science severity extent grade scales are minute light according to MMSE scoring, in, severe.
Slight: the above 20-23 Fen， 16-19 of primary school in schooling middle school divides, and illiteracy 13-16 divides.
Moderate: the above 11-19 Fen， 16-19 of primary school in schooling middle school divides, and illiteracy 13-16 divides.
Severe: above ≤10Fen， primary school≤7 minute, schooling middle school, illiteracy≤4 minute.
3, case inclusive criteria
3.1 meet the diagnostic criteria of doctor trained in Western medicine vascular dementia.Comprise 1. simple and easy mental status examination (MMSE) scoring: above ≤24Fen， primary school≤20 minute, schooling middle school, illiteracy≤17 minute; 2. ischemic score (HIS) >=7 minute; 3. it is more than three months that dull-witted morbidity must be after cerebrovascular morbidity, and the infringement of cognitive function is sudden or ladder, and symptom continues 3 months.
3.2 meet TCM syndrome diagnostic criteria.
3.3 according to simple and easy mental status examination (MMSE), and selection is slight and moderate dementia patient is the object of observation.
3.4 signing Informed Consent Forms.
3.5 patients should have good compliance to the O&A of research worker.
Allly meet above-mentioned five standard persons, can include case in.
4, case exclusion standard
4.1 do not meet vascular dementia diagnostic criteria.
4.2 do not meet TCM syndrome diagnostic criteria.
4.3 severe Patients with Vascular Dementia.
4.4 allergic constitutions and to multi-medicament allergy sufferers.
4.5 dementia patients in whole latter stage.
4.6 merge the serious primary disease such as cardiovascular, liver, kidney and hemopoietic system, and other organs functional defect.
4.7 suffer from the patient of cognitive disorder because of head injury.
4.8 suffer from some disease can disturb Cognitive Function, comprising being addicted to drink, taking drugs or other mental drug abuses person.
4.9 patients with serious neurologic impairment.
4.10 patient's state of an illness are critical, are difficult to the effectiveness of new drug and safety to make definite estimator.
4.11 during once system was accepted in the recent period, western medical treatment person.
Two, research method
1 clinical grouping
Clinical observation object 75 examples, the oldest 83 years old, minimum 40 years old; Male's 54 examples, women's 21 examples; The course of disease is the longest 7 years, the shortest 0.5 year; Schooling: middle school above 25Li， primary school 22 examples, illiteracy's 28 examples; Dementia degree: slight 46 examples, moderate 29 examples; By medical order, be divided into treatment group 50 examples, matched group 25 examples.
2 observe medicine
2.1 curatives: Chinese medicine of the present invention.
2.2 contrast medicines: hydergine tablet, main component Hydergine, by Tianjin Hua Jin pharmaceutical factory and Novartis Pharma Schweiz AG's co-production, authentication code: the accurate word H10910054 of traditional Chinese medicines, specification 1mg/ sheet.
3 Therapeutic Method
3.1 treatment groups: each 6 of oral Chinese medicine of the present invention, every day 3 times, continuous use 12 weeks.
3.2 matched groups: each 2 of oral hydergine tablet, every day 3 times, continuous use 12 weeks.
3.3 viewing durations are except predetermined treatment medication and merge the medicine that disease must continue to take, and ban use of other Chinese medicine that affects curative effect of medication and Western medicine.
4 observation items
4.1 observation index
4.1.1 safety observation: general physical examination project (body temperature, breathing, pulse, blood pressure); Blood, urine, stool routine inspection; The heart, liver, kidney function test; Blood examination; Electrocardioscopy; The untoward reaction that observation may occur, comprises the untoward reaction of the aspects such as symptom, sign, lab testing, analyzes untoward reaction reason, judges statistics adverse reaction rate, recording processing process and result etc.
4.1.2 health giving quality observation
4.1.2.1 cognitive function: with the cognitive function before and after the treatment of simple and easy mental status examination (MMSE) evaluate patient.
4.1.2.2 whole body performance and tongue, pulse condition situation: by tcm clinical practice symptom integral, improve the whole body performance before and after average evaluation patient treatment.
4.2 observation time points
4.2.1 cognitive function: monthly record is once before medication and after medication.
4.2.2 tcm symptom and tongue, pulse condition: monthly record is once before medication and after medication.
4.2.3 safety indexes observation: before and after medication, each record once.
5 efficacy assessment standards
5.1 cognitive function (as MMSE) curative effect: press nimodipine method and calculate, therapeutic index) (integration before (the front integration of integration-treatment after treatment) ÷ treatment) * 100%.
Clinical basic controlling: therapeutic index >=85%, or after treatment, integration reaches normal range;
Effective: therapeutic index >=50%, or integration lift-off value >=5 minute;
Effective: therapeutic index >=20%, or integration lift-off value >=3 minute;
Invalid: therapeutic index < 20%;
Worsen: therapeutic index >-20%.
5.2 tcm syndrome curative effects: press nimodipine method and calculate, therapeutic index) (integration before (the rear integration of integration-treatment before treatment) ÷ treatment) * 100%.
Clinical recovery: therapeutic index >=95%;
Effective: therapeutic index >=70%;
Effective: therapeutic index >=30%;
Invalid: therapeutic index < 30%;
6 statistical methods: measurement data adopts t check, enumeration data adopts x2 check, and ranked data adopt Ridit to analyze
Three, result
1 physical data: selected 75 routine patients all meet case inclusive criteria, is divided into treatment group 50 examples by medical order, matched group 25 examples, and be 12 weeks observing time.
Treatment group 50 examples, male's 36 examples, women's 14 examples; Minimum 42 years old of age, maximum 83 years old; The course of disease is the shortest 0.5 year, the longest 7 years; Schooling: middle school above 17Li， primary school 15 examples, illiteracy's 18 examples; Dementia degree: slight 31 examples, moderate 19 examples; Differentiation of symptoms and signs for classification of syndrome: renal deficiency type 21 examples, phlegm stagnation syndrome type 29 examples; Complication: merge a kind of disease 25 examples, merge two kinds of disease 13 examples, merge three kinds of disease 12 examples.Matched group 25 examples, male's 18 examples, women's 7 examples; Minimum 40 years old of age, maximum 80 years old; The course of disease is the shortest 0.5 year, the longest 6 years; Schooling: above 8 Li， primary school 7 examples in middle school, illiteracy's 10 examples; Dementia degree: slight 15 examples, moderate 10 examples; Differentiation of symptoms and signs for classification of syndrome: renal deficiency type 10 examples, phlegm stagnation syndrome type 15 examples; Complication: merge a kind of disease 12 examples, merge two kinds of disease 7 examples, merge three kinds of disease 6 examples.
Two groups of cases, aspect sex, age, the course of disease, schooling, dementia degree, pattern of syndrome distribution, complication, are learned and are processed there was no significant difference (P > 0.05) by statistics, point out the clinical data of two groups of cases to have comparability.
Observation of curative effect between 2 liang of groups
MMSE curative effect comparison between 2.1 liang of groups, in Table 4.
MMSE curative effect comparison between table 4 liang group
| Group | Number of cases | Clinical basic controlling | Effective | Effectively | Invalid | Worsen | Total effective rate (%) |
| Treatment group | 50 | 2 | 10 | 26 | 12 | 0 | 76 * |
| Matched group | 25 | 0 | 5 | 6 | 14 | 0 | 44 |
Note: *: compare P < 0.05 with matched group.
Two groups of curative effects are analyzed and are had significant difference (P < 0.05) through Ridit, and prompting treatment group MMSE comprehensive therapeutic effect is better than matched group.
Tcm syndrome curative effect comparison between 2.2 liang of groups, in Table 5
Tcm syndrome curative effect comparison between table 5 liang group
| Group | Number of cases | Clinical recovery | Effective | Effectively | Invalid | Total effective rate (%) |
| Treatment group | 50 | 3 | 12 | 25 | 10 | 80 * |
| Matched group | 25 | 1 | 6 | 8 | 10 | 60 |
Note: *: compare P < 0.05 with matched group.
Two groups of curative effects are analyzed and are had significant difference (P < 0.05) through Ridit, show that treatment group doctor syndrome comprehensive therapeutic effect is better than matched group.
Traditional Chinese medical science disease total mark comparison before and after 2.3 liang of group treatments, in Table 6.
Traditional Chinese medical science disease total mark comparison before and after table 6 liang group treatment
| Group | Before treatment | After treatment |
| Treatment group | 7.54±4.046 | 3.9±3.864 **△ |
| Matched group | 9.96±5.495 | 6.4±5.389 * |
Note: * *: after treatment group is treated and before treatment, compare P < 0.01; △: after the course for the treatment of, treatment group and matched group compare P < 0.05; * after treatment of control group with before treatment, compare P < 0.05.
Through t, check, after the treatment of tcm symptom total mark treatment group, before treatment, there is significant differences (P < 0.01), after treatment of control group, before treatment, there is significant difference (P < 0.05), after the course for the treatment of, between group, relatively have significant difference (P < 0.05).
MMSE integral contrast before and after 2.4 liang of group treatments, in Table 7.
MMSE integral contrast before and after table 7 liang group treatment
| Group | Before treatment | After treatment |
| Treatment group | 16±3.611 | 20±4.224 **△△ |
| Matched group | 14±4.280 | 16.84±5.408 * |
Note: * *: after treatment group is treated and before treatment, compare P < 0.01; △ △: after the course for the treatment of, treatment group and matched group compare P < 0.01; *: after treatment of control group with before treatment, compare P < 0.05.
Through t, check, after the treatment of MMSE integration treatment group, before treatment, there is significant differences (P < 0.01), after treatment of control group, before treatment, there is significant difference (P < 0.05), after the course for the treatment of, between group, relatively have significant differences (P < 0.01).
3. correlative factor and observation of curative effect
The Relationship Comparison of 3.1 treatment group sexes and curative effect, in Table 8, table 9.
The Relationship Comparison of table 8 treatment group sex and MMSE curative effect
| Sex | Number of cases | Clinical basic controlling | Effective | Effectively | Invalid | Worsen | Total effective rate (%) |
| Man | 36 | 1 | 7 | 21 | 7 | 0 | 80.56 |
| Female | 14 | 1 | 3 | 4 | 6 | 0 | 57.14 |
Through Ridit, analyze, between group, compare there was no significant difference (P > 0.05).
The Relationship Comparison of table 9 treatment group sex and tcm syndrome curative effect
| Sex | Number of cases | Clinical recovery | Effective | Effectively | Invalid | Total effective rate (%) |
| Man | 36 | 2 | 8 | 20 | 6 | 88.89 |
| Female | 14 | 1 | 4 | 4 | 5 | 64.29 |
Through Ridit, analyze, between group, compare there was no significant difference (P > 0.05).
The Relationship Comparison of 3.2 treatment group ages and curative effect, in Table 10, table 11.
The Relationship Comparison of table 10 treatment group age and MMSE curative effect
| Age | Number of cases | Clinical basic controlling | Effective | Effectively | Invalid | Worsen | Total effective rate (%) |
| < 55 years old | 16 | 1 | 4 | 8 | 3 | 0 | 81.25 |
| 55～70 years old | 22 | 1 | 3 | 12 | 6 | 0 | 72.73 |
| > 70 years old | 12 | 0 | 3 | 5 | 4 | 0 | 66.67 |
Through Ridit, analyze, between group, compare there was no significant difference (P > 0.05).
The Relationship Comparison of table 11 treatment group age and tcm syndrome curative effect
| Age | Number of cases | Clinical recovery | Effective | Effectively | Invalid | Total effective rate (%) |
| < 55 years old | 16 | 1 | 5 | 8 | 2 | 87 |
| 55～70 years old | 22 | 1 | 4 | 12 | 5 | 81.82 |
| > 70 years old | 12 | 1 | 3 | 5 | 3 | 75 |
Through Ridit, analyze, between group, compare there was no significant difference (P > 0.05).
The Relationship Comparison of the 3.3 treatment group courses of disease and curative effect, in Table 12, table 13.
The Relationship Comparison of the table 12 treatment group course of disease and MMSE curative effect
| The course of disease | Number of cases | Clinical basic controlling | Effective | Effectively | Invalid | Worsen | Total effective rate (%) |
| < 3 years | 33 | 2 | 10 | 14 | 7 | 0 | 78.79 * |
| > 3 years | 17 | 0 | 0 | 11 | 6 | 0 | 64.71 |
Note: *: with 3 years comparison P < 0.05 of >.
Through Ridit, analyze, the course of disease is short has significant difference (P < 0.05) compared with the long MMSE comprehensive therapeutic effect of the course of disease.
The Relationship Comparison of the table 13 treatment group course of disease and tcm syndrome curative effect
| The course of disease | Number of cases | Clinical recovery | Effective | Effectively | Invalid | Total effective rate (%) |
| < 3 years | 33 | 3 | 11 | 14 | 5 | 84.85 * |
| > 3 years | 17 | 0 | 1 | 11 | 5 | 70.59 |
Note: *: with 3 years comparison P < 0.05 of >.
Through Ridit, analyze, the course of disease is short has significant difference (P < 0.05) compared with the long tcm syndrome comprehensive therapeutic effect of the course of disease.
The Relationship Comparison of 3.4 treatment group schoolings and curative effect, in Table 14, table 15.
The Relationship Comparison of table 14 treatment group schooling and MMSE curative effect
| Schooling | Number of cases | Clinical basic controlling | Effective | Effectively | Invalid | Worsen | Total effective rate (%) |
| More than middle school | 17 | 0 | 0 | 12 | 5 | 0 | 70.59 |
| Primary school | 15 | 2 | 4 | 6 | 3 | 0 | 80 |
| Illiteracy | 18 | 0 | 6 | 7 | 5 | 0 | 72.22 |
Through Ridit, analyze, between group, compare there was no significant difference (P > 0.05).
The Relationship Comparison of table 15 treatment group schooling and tcm syndrome curative effect
| Schooling | Number of cases | Clinical recovery | Effective | Effectively | Invalid | Total effective rate (%) |
| More than middle school | 17 | 0 | 3 | 10 | 4 | 76.47 |
| Primary school | 15 | 2 | 4 | 6 | 3 | 80 |
| Illiteracy | 18 | 1 | 5 | 9 | 3 | 83.33 |
Through Ridit, analyze, between group, compare there was no significant difference (P > 0.05).
The Relationship Comparison of 3.5 treatment group dementia degrees and curative effect, in Table 16, table 17.
The Relationship Comparison of table 16 treatment group dementia degree and MMSE curative effect
| Dementia degree | Number of cases | Clinical basic controlling | Effective | Effectively | Invalid | Worsen | Total effective rate (%) |
| Slightly | 36 | 2 | 9 | 19 | 6 | 0 | 8.333 * |
| Moderate | 14 | 0 | 1 | 6 | 7 | 0 | 57.14 |
Note: *: compare P < 0.05 with moderate.
Through Ridit, analyze, slightly compared with moderate MMSE comprehensive therapeutic effect, have significant difference (P < 0.05).
The Relationship Comparison of table 17 treatment group dementia degree and tcm syndrome curative effect
| Dementia degree | Number of cases | Clinical recovery | Effective | Effectively | Invalid | Total effective rate (%) |
| Slightly | 36 | 3 | 10 | 19 | 4 | 88.89 * |
| Moderate | 14 | 0 | 2 | 6 | 6 | 57.14 |
Note: *: compare P < 0.05 with moderate.
Through Ridit, analyze, slightly compared with moderate tcm syndrome comprehensive therapeutic effect, have significant difference (P < 0.05).
The 3.6 treatment group pattern of syndrome Relationship Comparison with curative effect that distributes, in Table 18, table 19.
The Relationship Comparison of the distribution of table 18 treatment group pattern of syndrome and MMSE curative effect
| Pattern of syndrome distributes | Number of cases | Clinical basic controlling | Effective | Effectively | Invalid | Worsen | Total effective rate (%) |
| Renal deficiency type | 21 | 1 | 4 | 11 | 5 | 0 | 76.19 |
| Phlegm stagnation syndrome type | 29 | 1 | 6 | 14 | 8 | 0 | 72.41 |
Through Ridit, analyze, between group, compare there was no significant difference (P > 0.05).
The Relationship Comparison of the distribution of table 19 treatment group pattern of syndrome and tcm syndrome curative effect
| Pattern of syndrome distributes | Number of cases | Clinical recovery | Effective | Effectively | Invalid | Total effective rate (%) |
| Renal deficiency type | 21 | 1 | 5 | 12 | 3 | 85.71 |
| Phlegm stagnation syndrome type | 29 | 2 | 7 | 13 | 7 | 75.86 |
Through Ridit, analyze, between group, compare there was no significant difference (P > 0.05).
3.7 treatment groups merge the Relationship Comparison of diseases and curative effect, in Table 20, table 21.
Table 20 treatment group merges the Relationship Comparison of disease and MMSE curative effect
| Complication | Number of cases | Clinical basic controlling | Effective | Effectively | Invalid | Worsen | Total effective rate (%) |
| And a kind of disease | 25 | 2 | 9 | 10 | 4 | 0 | 84 *△ |
| And two kinds of diseases | 13 | 0 | 1 | 8 | 4 | 0 | 69.23 |
| And three kinds of diseases | 12 | 0 | 0 | 7 | 5 | 0 | 58.33 |
Note: *: with and two kinds of diseases P < 0.05 relatively; △: with and three kinds of diseases P < 0.05 relatively.
Through Ridit, analyze, and a kind of disease and two kinds of diseases, and three kinds of disease MMSE comprehensive therapeutic effects have significant difference (P < 0.05), and two kinds of diseases are and three kinds of disease MMSE comprehensive therapeutic effect there was no significant differences (P > 0.05).
Table 21 treatment group merges the Relationship Comparison of disease and tcm syndrome curative effect
| Complication | Number of cases | Clinical recovery | Effective | Effectively | Invalid | Total effective rate (%) |
| And a kind of disease | 25 | 3 | 10 | 9 | 3 | 88 △** |
| And two kinds of diseases | 13 | 0 | 2 | 8 | 3 | 76.92 |
| And three kinds of diseases | 12 | 0 | 0 | 8 | 4 | 66.67 |
Note: △: with and two kinds of diseases P < 0.05 relatively; *: with and three kinds of diseases P < 0.01 relatively.
Through Ridit, analyze, and a kind of disease and two kinds of disease tcm syndrome comprehensive therapeutic effects have significant difference (P < 0.05), and three kinds of disease tcm syndrome comprehensive therapeutic effects have significant differences (P < 0.01), and two kinds of diseases are and three kinds of disease tcm syndrome comprehensive therapeutic effect there was no significant differences (P > 0.05).
3.8 safeties detect
During two groups of patient's medications, all do not find anaphylaxis, the forward and backward vital sign of medication is without significant change, and blood, urine, stool routine, liver, renal function and the electrocardiogram of the forward and backward two groups of cases of medication be all without obviously changing, also not statistically significant of comparing difference between two groups.Forward and backward each hemorheology index difference not statistically significant of medication.Show Chinese medicine of the present invention in treatment vascular dementia process without obvious toxic-side effects, safe and reliable.
In sum, treatment by Chinese herbs vascular dementia of the present invention is curative effect there was no significant difference aspect sex, age, schooling, pattern of syndrome distribution, illustrates that it is scalable.But there is significant difference in course of disease length, dementia degree and complication aspect how many, research shows, the course of disease is short, and to be better than the course of disease long, and the state of an illness is slightly better than state of an illness moderate, merge a kind of disease and be better than merging various diseases, merge two kinds of diseases and merge no difference of science of statistics between three kinds of diseases.
Claims (5)
1. treat a medicine for vascular dementia, it is characterized in that it is the medicament of being made by the crude drug of following portions by weight: 30 parts, Rhizoma Gastrodiae, 50 parts of Rhizoma Polygonatis, 50 parts of Fructus Ligustri Lucidi, 15 parts of Pheretimas, 5 parts of Hirudos, 30 parts of Rhizoma Acori Graminei.
2. according to claim 1, state the medicine for the treatment of vascular dementia, it is characterized in that: it is to be active component by described 6 taste crude drug, add the medicament that pharmaceutically acceptable adjuvant or complementary composition are prepared from, described medicament is tablet, capsule, pill, granule or mixture.
3. prepare a method for the treatment of the medicine of vascular dementia described in claim 2, comprise the following steps:
A, standby according to described weight proportion weighting raw materials;
B, Pheretima, Hirudo, Rhizoma Acori Graminei are dried, pulverize, sieve, mix and make fine drug powder (I);
It is 1.30 ~ 1.40 that C, Rhizoma Gastrodiae, Rhizoma Polygonati, Fructus Ligustri Lucidi decoct, filter, are concentrated into relative density, makes clear paste (II);
D, get fine drug powder (I), clear paste (II) mixes, and adds pharmaceutically acceptable adjuvant or complementary composition to be prepared into pharmaceutically conventional medicament.
4. treat according to claim 3 the preparation method of the medicine of vascular dementia, it is characterized in that: the concrete preparation method of described pill is as follows:
A, standby according to described weight proportion weighting raw materials;
B, Pheretima, Hirudo, Rhizoma Acori Graminei are pulverized after drying 68 ~ 74 hours in 60 ℃, cross 100 mesh sieves, mix and make fine drug powder (I);
C, Rhizoma Gastrodiae, Rhizoma Polygonati, Fructus Ligustri Lucidi are soaked in water 0.5 ~ 1 hour, decoct with water several times, filter merging filtrate, and being concentrated into relative density is 1.30 ~ 1.40, makes clear paste (II);
D, get fine drug powder (I), clear paste (II) mixes, and pulverizes, and crosses 60 mesh sieves, with general method for making or mould method for making pill, obtains pill after dry.
5. treat according to claim 4 the preparation method of the medicine of vascular dementia, it is characterized in that: before mixing with fine drug powder (I), the clear paste that C step is made (II) microwave vacuum drying is made dry extract, design temperature is 60 ℃, negative pressure 0.08 ~ 0.09mpa, microwave power is 1.50 ~ 3.50kw, each 3 ~ 5min, and microwave vacuum drying amounts to 15 ~ 25min 4 ~ 6 times.
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Non-Patent Citations (4)
| Title |
|---|
| 张廷模.临床中药学.《临床中药学》.2011, * |
| 汪锐,等.天地精丸对血管性痴呆大鼠学习记忆能力及NO、NOS的影响.《中国中医急症》.2008,第17卷(第6期),参见讨论. * |
| 汪锐.天地精丸治疗血管性痴呆（肝肾亏虚兼痰瘀阻络证）的临床研究.《中国优秀硕士学位论文全文数据库医药卫生科技辑2008年第09期》.2008,E056-605，参见中文摘要、正文第12页. * |
| 谢艳.天地精丸治疗血管性痴呆的临床研究.《中国优秀博硕士学位论文全文数据库(硕士)医药卫生科技辑2006年第11期》.2006,E056-100,参见中文摘要、正文第12页. * |
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